At its inception, pop-up clinics in nontraditional settings provided some framework to build and operate a workplace clinic, but there was no precedent for mass vaccination during a public health emergency of this scale. Consequently, several challenges were presented. First, there were no guidelines for staffing, selecting a site, and operating with limited availability of COVID-19 vaccines. Second, infection control and safety protocols to protect clinic staff and patients (those receiving the vaccine) from COVID-19 in a mass vaccination setting were sparse. Third, an information management system to report site metrics to coordinating jurisdictions and manage employee medical records did not exist. Finally, the nation’s limited vaccine supply necessitated new protocols for tracking inventory and administering multiple manufacturers’ vaccines simultaneously. This article describes what we found to be key operational objectives that are clinically relevant and feasible in the workplace setting. PROGRAM DESIGN To establish an operational framework, the USPHS employed the Incident Command System (ICS), a proven model for coordinating emergency responses. This model is flexible in that management structure and operations can be adapted to the scale, complexity, and scope of an emergency. Incorporating personnel from various departments (facilities, pharmacy, clinical, security, and safety) introduced barriers to effective communication; these were negated through use of common terminology and objective-based management, both fundamental to the ICS framework. Other benefits of this model include a formal reporting system (the chain of command), a detailed staffing model with defined qualifications and responsibilities for each role, and appropriate staff-to-supervisor ratios to centralize efforts while ensuring safety and accountability.  All clinic staff, credentialed according to the institute’s standards, were subject to clinical competency assessments prior to onboarding. Before on-site orientation, clinic staff were introduced to mandatory safety measures, fit tested for N-95 respirators, and trained on donning and doffing personal protective equipment (such as face shields and gloves). Clinic staff received hands-on training in intramuscular administration techniques and how to operate safety devices for the several types of syringes used in the clinic. Orientation topics included CDC’s responses to FAQs regarding patient education, vaccine side effects, and protocols for managing high-risk patients. Clinicians then shadowed experienced peers and were observed before working independently. The clinic was conceived during a period of maximum telework; thus, a significant amount of unoccupied space was considered for hosting the operation. To determine the most appropriate location, sites were ranked based on functionality and environmental infection control factors. A modular configuration with outdoor waiting area, spacious observation seating, and separate entrance and exit for one-way patient flow was sought. Based on a 2016 study in Medical Care that found functional proximity significantly increased workplace influenza vaccination rates, a location central to campus, with accessibility and proper illumination, was also prioritized. Ventilation quality was quantified by the ratio of outdoor air exchange rate to personnel capacity. Finally, the availability of washable furniture with durable and nonporous surfaces for easy sanitization was also considered. The location ultimately selected was a vacant cafeteria in NIH’s Clinical Center (CC), which was complemented by an existing practice of pre-screening individuals for COVID-19 symptoms prior to entering the building. This checkpoint also issued fresh ASTM Level 3 surgical masks to all entrants; these masks were required to be worn within the facility, which was especially important to protect clinic staff and patients as local COVID-19 cases were high when the program was initiated. As this location’s occupant density was greater than that of other options, respirators were mandated for clinic staff because appropriate physical distance could not be ensured.

DOCUMENTATION One of the critical aspects of operation was documentation, which was necessary for managing procedures within the clinic and reporting to coordinating jurisdictions (the state of Maryland, the U.S. federal government, and CDC). NIH’s CC Department of Clinical Research Informatics developed and integrated cloud-based platforms for scheduling patient appointments, maintaining wait lists, managing medical records, and tracking clinic inventory. Cumulative, manufacturer-specific, and extrapolated metrics, such as percent of patients with adverse reactions and percent of vials with additional doses, were summarized in a data dashboard accessible to all clinic staff and NIH leadership to monitor the program’s progress and success (see Figure 1). Metrics were used to optimize clinic operations to increase efficiency, including estimating the number of vials to thaw and clinical providers to schedule as a function of the number of appointments. The systems also enabled the clinic to scale based on vaccine supply, which was often uncertain.

ADRIANA E. GOLDING is a post-doctoral research fellow in the Section on Integrative Biophysics, Division of Basic and Translational Biophysics at the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, in Bethesda, Maryland.

CAPT. DEREK A. NEWCOMER is a commissioned officer in the U.S. Public Health Service and is the deputy director of the Division of Occupational Health and Safety at the Office of Research Services, National Institutes of Health, in Bethesda, Maryland.

JUDY L. CHAN is a nurse practitioner in the Occupational Medical Service, Division of Occupational Health and Safety at the Office of Research Services, National Institutes of Health, in Bethesda, Maryland.

Send feedback to The Synergist.